CRESCENT WHITE UV PROTECTOR BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

CRESCENT WHITE UV PROTECTOR BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

CRESCENT WHITE UV PROTECTOR BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.00 %	Sunscreen
Homosalate 5.00 %	Sunscreen
Octisalate 5.00 %	Sunscreen
Octocrylene 2.70 %	Sunscreen
Oxybenzone 3.00 %	Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

water\aqua\eau butyloctyl salicylate methyl trimethicone neopentyl glycol diheptanoate aleurites moluccana (kukui) seed oil lauryl peg-9 polydimethylsiloxyethyl dimethicone peg-100 stearate butylene glycol glyceryl stearate dipentaerythrityl tri-polyhydroxystearate potassium cetyl phosphate laminaria ochroleuca extract scutellaria baicalensis root extract yeast polysaccharides algae extract caffeine cholesterol sorbitol glycyrrhetinic acid sodium hyaluronate stearic acid vp/eicosene copolymer ethylhexylglycerin caprylic/capric triglyceride saccharide isomerate caprylyl glycol tocopheryl acetate ammonium acryloyldimethyltaurate/vp copolymer dehydroxanthan gum sodium dehydroacetate cetyl alcohol citric acid sodium hydroxide silica tetrahexyldecyl ascorbate fragrance (parfum) disodium edta bht phenoxyethanol titanium dioxide (ci 77891) mica <iln40886>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

CRESCENT WHITE

UV
PROTECTOR
BROAD SPECTRUM
SPF 50

FULL CYCLE BRIGHTENING

ESTĒE LAUDER

1 FL. OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

CRESCENT WHITE UV PROTECTOR BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.0309 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.0515 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.0515 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.0278 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0309 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butyloctyl salicylate (UNII: 2EH13UN8D3)
methyl trimethicone (UNII: S73ZQI0GXM)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
KUKUI NUT OIL (UNII: TP11QR7B8R)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
peg-100 stearate (UNII: YD01N1999R)
butylene glycol (UNII: 3XUS85K0RA)
glyceryl monostearate (UNII: 230OU9XXE4)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
laminaria ochroleuca (UNII: 4R2124HE76)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
caffeine (UNII: 3G6A5W338E)
cholesterol (UNII: 97C5T2UQ7J)
sorbitol (UNII: 506T60A25R)
enoxolone (UNII: P540XA09DR)
hyaluronate sodium (UNII: YSE9PPT4TH)
stearic acid (UNII: 4ELV7Z65AP)
ethylhexylglycerin (UNII: 147D247K3P)
medium-chain triglycerides (UNII: C9H2L21V7U)
saccharide isomerate (UNII: W8K377W98I)
caprylyl glycol (UNII: 00YIU5438U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
dehydroxanthan gum (UNII: 63ZP7I1BQO)
sodium dehydroacetate (UNII: 8W46YN971G)
cetyl alcohol (UNII: 936JST6JCN)
citric acid monohydrate (UNII: 2968PHW8QP)
sodium hydroxide (UNII: 55X04QC32I)
silicon dioxide (UNII: ETJ7Z6XBU4)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
edetate disodium (UNII: 7FLD91C86K)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-045-01	1 in 1 CARTON	02/09/2015
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/09/2015

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-045) , REPACK(11559-045)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-045)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-045)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-045)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-045)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-045) , REPACK(11559-045)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-045) , REPACK(11559-045)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-045)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-045)